WARNING: Children should not use products that contain codeine after certain surgeries (including tonsil/adenoid removal). Also, this medication should not be used in children younger than 6 years due to an increased risk for serious (rarely fatal) breathing problems such as slow/shallow breathing. This infrequent side effect may occur even with usual prescribed doses. The lowest effective dose should be used, and other drugs that may slow down breathing should be avoided. For children between 6 and 12 years old, do not use this product to treat cough or pain unless specifically directed by the doctor. Some manufacturers also recommend that promethazine and other drugs that may also slow down breathing (such as the codeine in this product) should not be used together in children younger than 16 years. Get medical help right away if you notice symptoms of slow/shallow breathing (See also Side Effect section). Talk with your doctor or pharmacist about the risks and benefits of this medication.

USES: See also Warning Section.This combination medication is used to treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). Promethazine is an antihistamine that relieves watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Phenylephrine is a decongestant that relieves stuffy nose symptoms. Codeine is a narcoticcough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough.Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.

HOW TO USE: Take this medication by mouth with or without food, usually every 4 to 6 hours as needed with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication can be taken with food if stomach upset occurs. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor.Use a medication-measuring device to carefully measure the prescribed dose. Do not use a household spoon.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, withdrawal symptoms (such as anxiety, restlessness, sweating, shaking chills, nausea, vomiting, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.

SIDE EFFECTS: Drowsiness, dizziness, headache, lightheadedness, blurred vision, upset stomach, nausea, nervousness, trouble sleeping, constipation, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: involuntary behaviors/movements (e.g., fixed upward stare, neck twisting, tongue movements), mental/mood changes (e.g., hallucinations), ringing in the ears, shaking (tremors), trouble urinating, weakness.Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, easy bruising/bleeding, slow heartbeat, persistent nausea/vomiting, severe abdominal pain, yellowing eyes/skin.Codeine is changed into a strong narcotic drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, unusual drowsiness/difficulty waking up, confusion.This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other side effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), gallbladder disease, adrenal gland problem (e.g., Addison's disease), blood/immune system problems (e.g., bone marrowdepression), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema, sleep apnea), diabetes, glaucoma, heart problems (e.g., angina, irregular heartbeat), high blood pressure, liver disease, mental/mood problems (e.g., depression, psychosis), a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (e.g., ulcers, blockage), thyroid disease, trouble urinating (e.g., due to enlarged prostate or urethral stricture), use/abuse of drugs/alcohol.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit the use of alcohol and certain other medications that cause drowsiness. (See also Drug Interactions.)To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.This medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)Older adults may be more sensitive to the effects of the drug, especially dizziness, drowsiness, confusion, constipation, trouble urinating, trouble sleeping, fast/irregular heartbeat, or slow/shallow breathing. Dizziness, drowsiness, and confusion can increase the risk of falling.Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.This product passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your infant develops increased sleepiness, trouble breast-feeding, trouble breathing, or unusual limpness. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), cimetidine, methyldopa, metoclopramide, narcotic antagonists (e.g., naltrexone, naloxone), quinidine, reserpine.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as morphine).Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.This medication may interfere with certain laboratory tests (e.g., some pregnancy tests, blood sugar tests, amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, cold/clammy skin, fast/slow/irregular heartbeat, slow/shallow breathing, seizures, fainting.

NOTES: Do not share this medication with others. It is against the law.Do not take this medication for several days before allergy testing because test results can be affected.

MISSED DOSE: If you are prescribed this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.